Senior Regulatory Affairs Consultant - Ad Promo
Senior Regulatory Consultant – Advertising & Promotion (Strategic Lead) We are seeking a highly strategic and experienced Senior Regulatory Consultant – Advertising & Promotion to serve as a trusted advisor across cross-functional teams. This individual will bring deep expertise in FDA advertising and promotion regulations, providing guidance that shapes compliant, effective, and innovative healthcare communications. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk.
Key Responsibilities
- Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
- Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios
- Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements)
- Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy
- Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs
- Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy
- Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications
- Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations
- Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes
- Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders
- Mentor junior team members and contribute to building organizational regulatory capability
Qualifications
- 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
- Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
- Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
- Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
- Demonstrated ability to independently review promotional materials and make sound regulatory decisions
- Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly
- Excellent communication, influence, and stakeholder management skills
- Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset
Preferred Qualifications
- Experience supporting product launches or high-visibility brands
- Familiarity with global regulatory considerations (nice to have)
- Prior experience leading or facilitating MLR/PRC committees
What Sets This Role Apart
- Opportunity to operate as a strategic, enterprise-level regulatory leader
- High visibility across commercial and medical leadership teams
- Ability to directly influence brand strategy while ensuring compliance and patient safety
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